Comparison · NCT02239120-sae
Dabigatran Etexilate 110 or 150 Milligram (mg) vs Acetylsalicylic Acid, Aspirin (ASA) 100 mg: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Dabigatran Etexilate 110 or 150 Milligram (mg) vs Acetylsalicylic Acid, Aspirin (ASA) 100 mg: serious adverse events. Trial comparisons, record NCT02239120-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02239120-sae
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.271 | 0.254 | 0.288 | wilson | |
| Risk in group 2 | 0.277 | 0.26 | 0.294 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00619 | -0.0301 | 0.0177 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.978 | 0.896 | 1.07 | log | |
| Odds ratio, group 1 over group 2 | 0.969 | 0.86 | 1.09 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Dabigatran Etexilate 110 or 150 Milligram (mg) than on Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 162 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Dabigatran Etexilate 110 or 150 Milligram (mg) | Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to \<50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged \<75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily. | 724 | 2,676 | EG000 |
| Group 2 | Acetylsalicylic Acid, Aspirin (ASA) 100 mg | Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily. | 740 | 2,674 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse Events (AE) and serious AE starting between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months. All-cause mortality reported from randomisation until full follow up period, approximately 43 months.
Source ClinicalTrials.gov
Trial
- Title
- Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
- NCT number
- NCT02239120
- Phases
- PHASE3
- Conditions
- Stroke, Secondary Prevention
- Interventions
- optional ASA as comedication, placebo to ASA, placebo to optional ASA as comedication, placebo to dabigatran etexilate, ASA 100 mg, dabigatran etexilate
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2019-09-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02239120?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02239120-sae